BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 8152515 · Received December 11, 2018

    Report

    Report Number
    9610847-2018-00422
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 26, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED TWO UNITS. UNIT 1 WAS A USED Q-SYTE ONLY AND WAS WITHOUT PACKAGING AND ACCOMPANIED BY A HAND WRITTEN NOTE. UNIT 2 WAS A SEALED PACKAGE OF P/N 385100, LOT 7327640 WHICH CONTAINED A Q-SYTE INTACT WITH THE BLUE DUST CAP. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT #7327640 REGARDING ITEM #385100. DHR REVIEW WAS PREVIOUSLY CONDUCTED FOR THE SUB-ASSEMBLY LOTS (P/N 8004149) WHICH DISCLOSED THE FOLLOWING: 7325998: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON QFA LINE 2 FROM 29NOV17 THROUGH 1DEC17 7325504: A TOTAL OF (B)(UNITS WERE MANUFACTURED ON QFA LINE 3 FROM 1DEC17 THROUGH 3DEC17 BOTH OF THE LOTS ABOVE HAD A NON-RELATED TD (2017-89 FOR SCALES SWI) IMPLEMENTED DURING PRODUCTION. 7331828: A TOTAL OF (B)(4) WERE MANUFACTURED ON QFA LINE 3 FROM 6DEC17 THROUGH 8DEC17. ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES AND TESTING WERE PERFORMED IN ACCORDANCE WITH QUALITY CONTROL PLAN ALL PASSED PER SPECIFICATIONS. INVESTIGATION CONCLUSION: VISUAL EVALUATION: THERE WERE NO ANOMALIES OR DAMAGE TO THE EXTERNAL AREAS OF THE Q-SYTE UNIT; TOP BODY OR BOTTOM BODY (POLYCARBONATE). MICROSCOPIC EVALUATION: THE TOP DISK WAS SLIGHTLY LIFTED FROM THE TOP BODY IN ONE AREA. RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WERE PRESENT ON THE RIM OF THE TOP BODY (POLYCARBONATE) AND TOP DISK OF THE Q-SYTE UNIT; INDICATIVE OF A SUFFICIENT BOND AT TIME OF MANUFACTURE. OBSERVED THE SLIT AT THE SEPTUM TOP DISK WAS CENTERED IN ITS CORRECT POSITION. THERE WAS A TEAR AT EACH END OF THE SLIT AT THE SEPTUM TOP DISK SEPTUM COLUMN TEAR ASSESSMENT (METHOD-QCPA-13): THERE WAS A TEAR (COLUMN TEAR) TO THE COLUMN WALL NEAR THE VENT HOLE WATER LEAK TEST FOR ACTUATED AND UN-ACTUATED Q-SYTE (METHOD- MM-110): LEAKAGE DID NOT OCCUR FROM ANY AREA OF THE UNIT WHEN LEAK TESTED IN BOTH THE UN-ACTUATED AND ACTUATED POSITIONS. BOTTOM SEPTUM EVALUATION (METHOD-QCPA-13): CUT UNIT TO OBTAIN VIEW OF BOTTOM SEPTUM. OBSERVED THE SLIT AT THE SEPTUM BOTTOM DISK WAS CENTERED IN ITS¿ CORRECT POSITION AND THERE WAS A TEAR AT EACH END OF THE SLIT AT THE SEPTUM BOTTOM DISK. UNUSED UNIT (#2): VISUAL EVALUATION: THERE WERE NO ANOMALIES OR DAMAGE TO THE EXTERNAL AREAS OF THE Q-SYTE UNIT; TOP BODY OR BOTTOM BODY (POLYCARBONATE). MICROSCOPIC EVALUATION: OBSERVED THE SLIT AT THE SEPTUM TOP DISK WAS CENTERED IN ITS CORRECT POSITION. THERE WERE NO TEARS/DAMAGE TO THE SEPTUM TOP DISK OR THE SLIT. WATER LEAK TEST FOR ACTUATED AND UN-ACTUATED Q-SYTE (METHOD- MM-110): LEAKAGE DID NOT OCCUR FROM ANY AREA OF THE UNIT WHEN LEAK TESTED IN BOTH THE UN-ACTUATED AND ACTUATED POSITIONS. NO OTHER ANOMALIES OR DAMAGE WAS OBSERVED. NOTE: THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE ALLEGED FAILURE STATED IN THE PIR. ROOT CAUSE DESCRIPTION: THERE WAS EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS IN THE AREA OF THE TOP DISK AND TOP BODY, WHERE THE DISK WAS SLIGHTLY LIFTED, WHICH INDICATED THAT A SUFFICIENT BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FAILURE MODE ASSOCIATED WITH THE RETURNED USED SAMPLE DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM TOP DISK AND THE COLUMN TEAR, COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE ALLEGED DEFECT. RATIONALE: A FORMAL CORRECTIVE ACTION HAS NOT BEEN INITIATED AT THIS TIME. A DEFINITE MANUFACTURING RELATED ROOT CAUSE COULD NOT BE ESTABLISHED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ Q-SYTE CLOSED LUER ACCESS DEVICE WAS LEAKED DURING USE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ Q-SYTE CLOSED LUER ACCESS DEVICE WAS LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989290 BD¿ Q-SYTE CLOSED LUER ACCESS DEVICE CATHETER INJECTION PORT FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7327640 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other